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European Medicines Agency Approves Pediatric Investigational Plan for Pixuvri
Date:11/17/2010

SEATTLE, Nov. 17, 2010 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the European Medicines Agency ("EMA") approved CTI's Pixuvri (pixantrone dimaleate) Pediatric Investigation Plan ("PIP") for the treatment of lymphoid malignancies and solid tumors in children between the ages of six months and 18 years. Previously, the Pediatric Committee (the "PDCO") of the EMA adopted an opinion agreeing to the PIP and a deferral of the initiation of the clinical studies until after the drug receives EMA approval.  CTI has submitted a Marketing Authorization Application ("MAA") for Pixuvri approval in Europe as monotherapy for the treatment of adult patients with multiply relapsed or refractory, aggressive non-Hodgkin's lymphoma ("NHL"). CTI expects that the EMA will make a determination regarding the acceptance of the Pixuvri MAA submission for review this month.

About PixantronePixantrone is a novel aza-anthracenedione that has distinct structural and physio-chemical properties that make its anti-tumor activity unique in this class of agents. Similar to anthracyclines, pixantrone inhibits Topo-isomerase II but unlike anthracyclines--rather than intercalation with DNA--pixantrone alkylates DNA--forming stable DNA adducts, with particular specificity for CpG rich, hyper-methylated sites. We believe that these structural differences resulted in significantly enhanced anti-lymphoma activity compared to doxorubicin in preclinical models. In addition, we believe the structural motifs on anthracycline-like agents that are responsible for the generation of oxygen free radicals and the formation of toxic drug-metal complexes have also been modified in pixantrone to prevent the binding of iron and perpetuation of superoxide production--both of which are the putative mechanism for anthracycline induced acute cardiotoxicity. These novel pharmacologic differences may allow re-introduction of anthracycline like potency in the t
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SOURCE Cell Therapeutics, Inc.
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